Kornimate/medical-research-clean huggingface dataset:
therapeutic vaccination followed by treatment interruption in hiv infected patients

Conditions: HIV Infections

Summary: the aim of this trial is to find out if immune responses to hiv can be boosted in individuals who start medicines soon after being infected. if immune responses can be boosted to the virus, this may allow the body to control hiv without the need for medications. this study is designed to test a new strategy for boosting immune responses to hiv and to evaluate if these responses allow people to have control of hiv without medicines.

the novel strategy used in this trial is to mix a peptide vaccine with dendritic cells from individuals. the dendritic cells are normal cells in the blood that boost immune responses. in hiv uninfected people, dendritic cells have been found to strongly activate the types of immune responses that may be important in controlling hiv. hiv infected and hiv uninfected individuals in this study will receive one shot of dendritic cells alone followed by three monthly shots of dendritic cells plus vaccine. we will monitor the immune responses to the peptide vaccine during this time period. after completing the vaccinations, hiv infected patients will stop their hiv medications and their immune status (cd4 count) and viral load will be monitored closely over 12 weeks.

Eligibility criteria:
inclusion criteria: both hiv infected and hiv uninfected individuals are eligible for this study. * cd4 cell count of 400 cells/mm3 or greater at study entry * if hiv infected, initiated anti-hiv medicines within 120 days of infection * if hiv infected, hiv viral load \< 50 copies/ml for at least 3 months prior to study entry * current medication regimen for at least 3 months prior to study entry * a particular blood type (hla-a\*0201) * acceptable methods of contraception exclusion criteria: * received investigational drug or vaccine within 30 days prior to study entry * on other immune-based therapy (e.g., interleukin-2, alpha interferon, immunoglobulin, thalidomide) within 30 days prior to study entry * megesterol acetate within 30 days prior to study entry * immunization within 4 weeks of study entry * if hepatitis b virus (hbv) uninfected and at high risk for hbv infection, the patient will not be eligible until he or she has completed an hbv vaccine series. * unstable or severe medical condition, including active opportunistic infection requiring treatment * history of hashimoto's thyroiditis * cancer requiring chemotherapy within 6 months prior to study entry * history of radiation therapy to axillary lymph nodes * significant laboratory abnormalities at study entry * pregnant or breastfeeding * history of autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus, autoimmune hepatitis, scleroderma, mixed connective tissue disorder) * allergy to gentamicin, tobramycin, streptomycin, or amikacin

Keywords: dendritic cell immunotherapy acute hiv human immunodeficiency virus aids hiv therapeutic vaccine treatment experienced treatment interruption
a study to evaluate efficacy and safety of deucravacitinib in participants with active discoid and/or subacute cutaneous lupus erythematosus (dle/scle)

Conditions: Lupus Erythematosus, Discoid; Lupus Erythematosus, Subacute Cutaneous

Summary: the purpose of this study is to assess the safety, efficacy, and tolerability of deucravacitinib (bms-986165) compared with placebo in participants with active discoid and/or subacute cutaneous lupus erythematosus (dle/scle). this study will also assess if deucravacitinib is biologically active and potentially effective in the treatment of participants with moderate to severe dle/scle with or without systemic lupus erythematosus (sle) that is not well controlled with standard of care therapy.


Eligibility criteria:
inclusion criteria: * diagnosis of discoid/subacute cutaneous lupus erythematosus (dle/scle) for at least 3 months prior to screening visit * meets both clinical and histopathological diagnostic cutaneous lupus erythematosus (cle) criteria per protocol * currently receiving treatment for dle/scle with a stable regimen of at least one of the following medications: oral corticosteroid, and/or antimalarial, and/or immunosuppressant * participant could be with or without concurrent systemic lupus erythematosus (sle) * if participant receives nonsteroidal anti-inflammatory drugs (nsaids) or analgesics treatment then the participant must be on a stable dose 2 weeks prior to screening exclusion criteria: * women who are pregnant, lactating, breastfeeding or planning pregnancy during the study period * any of the following specific cle subtypes in isolation: acute cutaneous lupus erythematosus (acle), lupus tumidus, lupus (profundus) panniculitis, chilblains * drug-induced cle and/or drug-induced systemic lupus erythematosus (sle) * antiphospholipid antibody syndrome, serious thrombotic event or unexplained pregnancy loss within 1 year before the screening visit * history of 3 or more unexplained consecutive pregnancy losses * active severe or unstable neuropsychiatric sle * other autoimmune diseases or non-sle driven inflammatory joint or skin disease or overlap syndromes as primary disease that in the opinion of the investigator will significantly impact the assessment of cle/sle disease manifestations and activity other protocol-defined inclusion/exclusion criteria apply

Keywords: bms-986165 deucravacitinib dle discoid lupus erythematosus scle subacute cutaneous lupus erythematosus
the effects of potassium on physiological and cardiovascular variables in healthy persons

Conditions: Hypertension

Summary: in humans living of fruit and vegetables, hypertension is rarely seen. we wish to study if the development of hypertension has a connection to our intake of potassium. we know that fruit and vegetables contain a lot of potassium and we will simulate this intake by giving healthy subjects potassium as tablets.


Eligibility criteria:
inclusion criteria: * healthy * age 18-40 years old * bmi 18, 5-30 * non-smoker exclusion criteria: * daily use of medicine * alcohol or drugs * desire to become pregnant * not using safe anti-contraceptive * abnormal results in the initial testing

Keywords: hypertension potassium blood pressure
examining the link between trace elements and cardiovascular disease risk factors in young adults

Conditions: Cardiovascular Diseases; Metabolic Syndrome X; Hypertension; Inflammation; Atherosclerosis

Summary: cardiovascular disease (cvd) affects millions of people in the united states; each year, more people die from cvd than from any other disease. there are many dietary and lifestyle factors that may increase the risk of developing cvd. preliminary research has shown that the presence of certain trace elements may be associated with the development of cvd. this study will examine toenail clippings and laboratory data to evaluate the link between trace elements and cvd risk factors in young adults.

cvd is a disorder that affects the heart's ability to function normally. the most common cause of heart disease is narrowing or blockage of the coronary arteries, which supply blood to the heart. there are many risk factors for cvd, including inflammation, high blood pressure, high cholesterol, and obesity. small quantities of trace elements, also known as micronutrients, are essential in maintaining a healthy body. research has shown that some trace elements may be associated with the development of cvd, but more research is needed to confirm this connection. this study will examine concentrations of several trace elements in toenail samples of young adults participating in the coronary artery risk development in young adults (cardia) study. the cardia study is measuring changes in cvd risk factors in individuals as they age and is identifying lifestyle habits that influence those changes. the purpose of this study is to determine the link between trace elements and cvd risk factors in young adults. the results of this study may help to identify whether dietary, lifestyle, or environmental factors can be modified at a young age to prevent the development of cvd. this study will examine laboratory and medical history data of participants who are already enrolled in the cardia study; there are no additional study visits specifically for this study. toenail samples collected from participants during their year 2 cardia study visit in the late 1980's will be examined to determine the presence of selenium, chromium, arsenic, and mercury. participants' cardia study data will be reviewed and several cvd risk factors will be analyzed, including the thickness of heart arteries; calcium buildup within the arteries; inflammatory markers, such as high sensitivity c-reactive protein and interleukin 6; blood pressure levels; body weight; and levels of cholesterol, fat, and sugar.

Eligibility criteria:
inclusion criteria: * enrolled in the cardia study; this current study will be using existing cardia study data and will not be recruiting any new participants
efficacy of oral tobacco products compared to a medicinal nicotine

Conditions: Tobacco Use Disorder

Summary: for the primary goals, we hypothesize that 1) the oral tobacco product will be more efficacious than the medicinal nicotine product in substituting for smoking cigarettes; 2) among non-abstainers, the oral tobacco product will lead to greater reduction in cigarette smoking than medicinal nicotine; and 3) a higher rate of oral tobacco compared to medicinal nicotine use will be observed during and beyond the treatment period. for the secondary goals, we hypothesize that 1) both products will equally reduce withdrawal symptoms from cigarette abstinence; and 2) the toxicant exposure and toxicity will be reduced dramatically when smokers switch from cigarettes to each of these products; however, this reduction will be greater with the use of medicinal nicotine.

this second study under "oral tobacco as a harm reduction product" grant is a clinical trial. subjects will be randomized to the brand of smokeless tobacco that is determined to be most effective in study 1 or to nicotine gum for 12 weeks to compare complete substitution for smoking. the secondary aims are to determine the effects of the products on biomarkers of exposure and toxicity. other secondary aim includes examining the effects of the two products on withdrawal symptoms. two sites will be used for these studies: university of minnesota and oregon research institute (ori).

Eligibility criteria:
inclusion criteria: * smoking at least 10 cigarettes daily for the past year, * in good physical health (no unstable medical condition; * no contraindications for medicinal nicotine, as appropriate for the study, stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the dsm-iv criteria). exclusion criteria: subjects must not be currently using other tobacco or nicotine products; female subjects cannot be pregnant or nursing.

Keywords: oral tobacco products snus smoking substitution harm reduction biomarkers of tobacco exposure
vibrant registry: value of information based from pacemaker recordings and new technologies

Conditions: Pacemaker; Bradycardia

Summary: the purpose of this study is to collect data from pacemakers and determine how this information is used by physicians to care for their patients with pacemakers.

the purpose of this registry is to gain a better understanding of how diagnostic capabilities in four vitatron pacemakers (selection afm, clarity, c-series, and t-series) are being utilized for the clinical management of a general pacing population. pacemaker information and health status is collected from all patients enrolled.

Eligibility criteria:
inclusion criteria: • class i or class ii indication for dual chamber pacing exclusion criteria: * has an icd or is a known candidate for an icd

Keywords: registry pacemaker diagnostics
the effect of smoking on perception

Conditions: Nicotine Dependence

Summary: the purpose of the experiment is to examine the effect of smoking on how individuals recognize and interpret sensory information.

participation requires one 90-minute visit on the american university campus that involves completing questionnaires and computer tasks, watching a film, and smoking a cigarette. participants earn 30 dollars.

Eligibility criteria:
inclusion criteria: * between ages 18 and 60 * regular, daily smoker * smoke for at least 1 year exclusion criteria: * color blind * smoking related health problems (chronic bronchitis, chronic obstructive pulmonary disease, emphysema)

Keywords: smoking
nicardipine to avoid spasm in trans radial percutaneous coronary intervention

Conditions: Spasm Artery

Summary: radial artery is the recommended route for percutaneous coronary intervention for it significantly reduces net adverse clinical events compared to the femoral approach. the success of the radial approach is therefore of a paramount importance. however, radial artery spasm (ras) remains one of the major limitations of transradial approach (tra) and the most frequent cause of tra failure. several recommendations has been issued to improve success rate when using the radial route. in the tunisian difficult economic context, the use of low end equipment, the unavailability of nitroglycerine and calcium antagonist verapamil, has led to the general feeling that ras and tra failure has subsequently increased. the standard and only used protocol by the tunisian interventional cardiologist, consists of administrating 1 mg isosorbide dinitrate through the arterial sheath immediately after radial arterial puncture, therefore limiting the options to prevent ras. nicardipine is the only injectable calcium antagonist available in tunisia. its spasmolytic action on radial artery has been well demonstrated when used in cabg. however, it has been very poorly investigated in trans radial percutaneous coronary intervention. investigators believe that the concomitant use of nicardipine with isorbide might significantly reduce ras and tra failure when compared to isosorbide dinitrate only.


Eligibility criteria:
inclusion criteria: * all patients scheduled for coronary intervention will be eligible for screening (coronarography or coronary angioplasty). * participant is willing and is able to give informed consent for participating in the trial. * male or female, aged 18 years or above. exclusion criteria: * planned femoral approach because no radial pulse was perceived * cardiogenic shock * coronary intervention for st elevation myocardial infarction during the night shift.

Keywords: radial artery spasm
trial on endovascular aneurysm management

Conditions: Brain Aneurysm

Summary: the management of patients with unruptured aneurysms is controversial. patients with unruptured aneurysms may suffer intracranial hemorrhage, but the incidence of this event is still debated. endovascular treatment can prevent rupture, but involves immediate risks; furthermore, successful treatment does not eliminate all risks. a randomized trial may be the best way to demonstrate the potential benefits of endovascular over conservative management of unruptured aneurysms.

this study is designed as a pragmatic trial. all candidates for endovascular treatment of one or more unruptured intracranial aneurysms will be offered to participate. unruptured aneurysms may be recently discovered or prevalent. if they accept, subjects will be randomized to one of the two arms of the trial: conservative management (observation) or endovascular treatment. both groups will be advised to obtain medical treatment for hypertension if necessary and will receive counselling for behavioural risk factor modelling (smoking or excessive drinking) when indicated. a non-invasive (mra or cta) or catheter angiogram and a baseline ct-scan or mri of the brain are required to enter the study. these studies should demonstrate the unequivocal presence of a saccular aneurysm \>=3 mm treatable by endovascular methods. a catheter angiogram is required if there is doubt. imaging studies will be reviewed centrally. both treatments will be standardized. patients will be followed similarly for a minimum of 10 years.

Eligibility criteria:
inclusion criteria: * at least one documented subarachnoid aneurysm, never ruptured * patient aged 18 or older * life expectancy more than 10 years exclusion criteria: * patients with recent (less than 3 months) intracranial haemorrhage * lesion characteristics unsuitable for endovascular treatment * patients with a single extradural aneurysm * aneurysms \< 3 mm or giant aneurysms (≥ 25 mm) * patients with a poor outcome (rankin scale ≥ 3) after the rupture, surgical or endovascular treatment of another aneurysm * patients with incompletely treated aneurysms that have previously ruptured * patients with associated arteriovenous malformations * patients with new severe progressive symptoms in relationship with the aneurysm (sudden onset, severe persisting headaches suggestive of impending rupture, third-nerve palsy, mass-effect) * patients with previous intracranial haemorrhage from unknown etiology * patients with multiple unruptured aneurysms in whom surgical clipping of one or many aneurysms is planned in addition to endovascular management * patients with absolute contraindications to anaesthesia, endovascular treatment, or administration of contrast material, including low-osmolarity agents or gadolinium * pregnant patients * patients unable to give informed consent

Keywords: aneurysm brain unruptured observation treatment endovascular
obesity intervention "obeldicks" for obese children, adolescents and their parents

Conditions: Obesity

Summary: the intervention program "obeldicks" was developed for obese children aged 6 to 16 years. this intervention is gender- and age specific. the 12-months intervention is based on nutrition course, behaviour therapy and exercise therapy. the evaluation compromised quality of structure, process and results of the intervention. primary outcome measure is change of weight status as standard deviation score of bmi. furthermore, cardiovascular risk factor profile, hormones (e.g. igf-i, thyroid hormones, vitamin d status)adipocytokines, gi- hormones, intima media thickness are measured prior to and after the one-year intervention. the changes of these hormones and adipocytokines will allow to answer the questions whether the alterations of these hormones are a cause or consequence of overweight. additionally, a genetic screening is performed to characterize the participants to probably predict response to intervention.


Eligibility criteria:
inclusion criteria: * bmi\> 97. percentile for age and gender exclusion criteria: * psychiatric disorders * endocrine disorders
learning skills together pilot study

Conditions: Family Caregiving; Complex Care; Self Efficacy; Intervention

Summary: the learning skills together (lst) program is a synchronous web-based educational intervention developed to address the essential need for training to equip family caregivers to someone with mid-stage alzheimer's disease to confidently provide complex care tasks.the purpose of this pilot study is to evaluate the feasibility of delivering lst, the program's acceptability to caregivers, and likelihood of effecting caregivers self-efficacy and mastery.


Eligibility criteria:
inclusion criteria: * family member (including families of choice) to an individual living with alzheimer's disease who has received a diagnosis from a physician * ages 18 and old * provides assistance with at least two instrumental activities of daily living or one activity of daily living * care recipient is described as being within mid-stage alzheimer's disease * there are no plans to place the care recipient in a skilled nursing facility within the next 3 months exclusion criteria: * the caregiver is paid to provide care * the caregiver does not have reliable access to a computer and internet * the caregiver is unable to read and speak english
sexual dimorphism in cardiovascular autonomic neuropathy in patients with type 1 diabetes

Conditions: type1diabetes

Summary: sex might interact with cardioautonomic neuropathy (can) in the development of macrovascular disease in patients with type 1 diabetes (t1d). the regulation of the autonomic system shows sexual dimorphism, and may contribute to the cardiovascular risk overload in women with t1d. the aims of this project are: a.1) determining the prevalence of can and subclinical atherosclerosis in a large cohort of consecutive patients with t1d as a function of sex (cross-sectional study). a.2.) addressing the progression of can and subclinical atherosclerosis in patients with t1d as a function of sex (longitudinal prospective study). a.3.) investigating the influence of sex steroids and circulating biomarkers in the development and progression of can and subclinical atherosclerosis. research designs: a cross-sectional design/prevalence screening study determining the prevalence of can as a function of sex in 320 consecutive individuals with dm1. a longitudinal prospective study: the cohort of prevalence screening study will be prospectively followed, and the assessment of cardiovascular autonomic function and subclinical atherosclerosis will be repeated over time.


Eligibility criteria:
inclusion criteria: - diagnosis of type 1 diabetes mellitus, as defined by ada criteria exclusion criteria: * renal transplantation or renal replacement therapy; * prior diagnosis of macrovascular disease (chd, cerebrovascular disease, carotid disease, pad, or atherosclerotic aortic aneurism); * ongoing pregnancy; * diagnosis of types of diabetes mellitus other than type 1; * diagnosis of types of neuropathy other than diabetic neuropathy.

Keywords: cardioautonomic neuropathy sexual dimorphism subclinical atherosclerosis
study of su011248 in combination with paclitaxel in patients with metastatic breast cancer

Conditions: Breast Neoplasms

Summary: this study is to evaluate the safety of su011248 in combination with paclitaxel in patients with metastatic or locally recurrent breast cancer who have not received chemotherapy treatment in the advanced disease setting.


Eligibility criteria:
inclusion criteria: * breast cancer with evidence of unresectable, locally recurrent or metastatic disease. * candidate for treatment with paclitaxel. exclusion criteria: * prior chemotherapy in the advanced disease setting. * her2 positive disease unless previously treated with trastuzumab.